On October 30, 2019 Cerus Corporation (Nasdaq: CERS) reported financial results for the third quarter ended September 30, 2019 (Press release, Cerus, OCT 30, 2019, View Source [SID1234550032]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Recent developments and highlights include:

FDA issued its final guidance document on strategies to mitigate the risk of bacterial contamination in transfused platelet components
Total third quarter revenue of $22.8 million
Quarterly product revenue of $18.0 million, a 17% increase compared to the prior year quarter
Government contract revenue of $4.8 million
Worldwide demand for INTERCEPT continued to increase; calculated number of treatable platelet doses increased nearly 20% worldwide compared to the prior year quarter
2019 product revenue guidance reaffirmed at $72 million to $75 million, up 18-23% over 2018, driven by strong global demand for INTERCEPT platelets
Over 20 posters and abstracts presented at the 2019 AABB Conference, highlighting the clinical and operational benefits of INTERCEPT
"The recent finalization of the FDA guidance document is great for patients, transfusion medicine and Cerus," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. "INTERCEPT is uniquely positioned to provide a solution for blood centers to comply with the final guidance that confers optimal operational simplicity, clinical efficacy, and economic value to blood centers and hospitals. In this regard, the American Red Cross and many other large U.S. blood centers have stated that pathogen reduction is their preferred solution to safeguarding the platelet supply."

"We have built a strong foundation of awareness for INTERCEPT as evidenced by another quarter of strong commercial execution with the calculated number of treatable platelet doses in the U.S. up nearly 70% compared to the prior year. With this solid base of existing blood center customers scaling their production of INTERCEPT platelets, we are ramping our efforts to support U.S. blood centers and hospitals to be compliant with the FDA’s final guidance document by the end of Q1 2021," continued Greenman.

Revenue

Product revenue during the third quarter of 2019 was $18.0 million, compared to $15.4 million during the same period in 2018. Revenue growth in the quarter benefited from continued demand for INTERCEPT platelet kits in the U.S. and the timing of large plasma kit orders in EMEA, which were partially offset by the conversion to our double dose platelet kits in France and a 4% negative impact of foreign currency exchange rates. Year-to-date product revenue totaled $53.7 million, an increase of 21% compared to the same period in 2018.

Government contract revenue from the Company’s Biomedical Advanced Research and Development Authority (BARDA) agreement was $4.8 million during the third quarter of 2019, compared to $3.9 million during the same period in 2018, as a result of increasing INTERCEPT red blood cell clinical and development activities. Year-to-date government contract revenue totaled $13.6 million compared to $11.4 million in the first nine months of 2018. The total potential value of the current BARDA agreement is $201 million with $39 million recognized as revenue to date.

BARDA is part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. The development of the INTERCEPT red blood cell program has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600009C.

Gross Margins

Gross margins on product revenue during the third quarter of 2019 were 58%, compared to 47% for the third quarter of 2018. The increase in gross margin was tied to economies of scale realized for our cost of goods sold, favorable platelet product mix, namely the French conversion to double dose platelet kits and additional manufacturing efficiencies. Gross margins during the first nine months of 2019 were 55% compared to 48% reported in the same period the year prior.

Operating Expenses

Total operating expenses for the third quarter of 2019 were $32.2 million compared to $24.8 million for the same period the prior year. Year-to-date, operating expenses totaled $93.0 million compared to $72.2 million for the first three quarters of 2018.

Selling, general, and administrative (SG&A) expenses for the third quarter of 2019 totaled $16.1 million, compared to $14.0 million for the third quarter of 2018. The year-over-year increase in SG&A expenses was tied to increased non-cash stock compensation, higher investments in our supply chain capabilities and focused investments on preparatory activities for our anticipated cryoprecipitate launch. Year-to-date SG&A expenses totaled $49.0 million compared to $42.0 million for the first nine months of 2018.

Research and development (R&D) expenses for the third quarter of 2019 were $16.1 million, compared to $10.8 million for the third quarter of 2018. The increase in year-over-year R&D expenses was largely due to product enhancements and initiatives for expanded label claims, development activities to support our anticipated cryoprecipitate PMA supplement, as well as additional activities tied to the development of our INTERCEPT red blood cell system. Year-to-date R&D expenses totaled $43.9 million compared to $30.1 million for the first nine months of 2018.

Net Loss

Net loss for the third quarter of 2019 was $18.0 million, or $0.13 per diluted share, compared to a net loss of $14.2 million, or $0.11 per diluted share, for the third quarter of 2018. Year-to-date net loss was $54.3 million or $0.39 per diluted share compared to $41.4 million, or $0.32 per diluted share in the first nine months of 2018.

Cash, Cash Equivalents and Investments

At September 30, 2019, the Company had cash, cash equivalents and short-term investments of $85.1 million, compared to $117.6 million at December 31, 2018.

At September 30, 2019, the Company had approximately $39.4 million in outstanding term loan debt and $5.0 million of borrowings under its revolving loan credit agreement, compared to $29.9 million in outstanding term loan debt at December 31, 2018.

2019 Product Revenue Guidance

The Company reaffirms its 2019 product revenue guidance to the range of $72 million to $75 million. The guidance range represents 18% to 23% growth compared to 2018 reported product revenue and is based on the strong global demand for INTERCEPT platelet kits.

QUARTERLY CONFERENCE CALL AND WEBCAST

The Company will host a conference call and webcast at 4:30 P.M. EDT this afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook. To listen to the live webcast and view the presentation slides, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on the Company’s website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 2392137. The replay will be available approximately three hours after the call through November 13, 2019.

On October 30, 2019 ImmunSYS, Inc., a clinical stage biotechnology company focused on the development of YourVaccx, a new intratumoral immunotherapy system for metastatic castrate resistant prostate cancer and other solid tumor cancers, reported that the company received the top award at the recent BioPitch 2019, a Shark Tank for life science companies that highlighted the 2019 BioFlorida annual conference (Press release, ImmunSYS, OCT 30, 2019, View Source [SID1234550064]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The company won $10,000 after besting 15 other seed-stage and early-stage life science firms that also pitched at the Oct. 22 conference in Tampa. More than 20 investor judges worked over the past several months to review a record-breaking number of applications for BioPitch, and they determined the 16 semi-finalists who presented at the conference, said Jane Teague, who organized the pitch competition and is executive director of the Institute for Commercialization of Florida Technology.

In addition to the pitch competition, the conference featured biotech leaders presenting research updates, and panels discussing the state of the industry in Florida.

To learn more about ImmunSYS and BioPitch 2019, you can read the recap here: https://stpetecatalyst.com/meet-the-company-that-won-10000-at-biopitch

On October 30, 2019 CytoSorbents Corporation (CTSO), a critical care immunotherapy leader commercializing its CytoSorb blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, reported that it will report Q3 2019 financial results after the market close on Tuesday, November 5, 2019 (Press release, Cytosorbents, OCT 30, 2019, View Source [SID1234550080]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

CytoSorbents’ management will host a live conference call and presentation webcast that will recount both operational and financial progress during Q3 2019 followed by a question and answer session.

Conference Call Details:
Date: Tuesday, November 5, 2019
Time: 4:45 PM Eastern
Participant Dial-In: 877-451-6152
Conference ID: 13695453
Live Presentation Webcast: View Source

It is recommended that participants dial in approximately 10 minutes prior to the start of the call. There will also be a simultaneous live webcast of the conference call that can be accessed through the following audio feed link: View Source

An archived recording of the conference call will be available under the Investor Relations section of the Company’s website at View Source

On October 30, 2019 Dendreon Pharmaceuticals, a commercial-stage biopharmaceutical company and pioneer in the development of immunotherapy, reported early completion of patient enrollment of its Phase 3 ProVent clinical trial. More than 450 subjects were randomized in the large-scale clinical trial, which is evaluating the effectiveness of sipuleucel-T (PROVENGE) in reducing disease progression in men with early-stage prostate cancer on active surveillance (AS) (Press release, Dendreon, OCT 30, 2019, View Source [SID1234550065]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The rapid pace of enrollment in the ProVent trial is a significant milestone for Dendreon, and underscores a strong interest by patients and physicians in the potential clinical benefit of sipuleucel-T in men on AS," said Bruce A. Brown, M.D., chief medical officer at Dendreon. "PROVENGE has been proven to extend life in men with mCRPC, and we intend to change the way prostate cancer is treated by showing that immunotherapy can reduce disease progression and the need for aggressive intervention in men with early-stage disease."

Nearly 175,000 men are diagnosed with prostate cancer every year.1 Of these, about 30 to 40% with a lower risk of prostate cancer will opt for AS, which includes regular monitoring to assess whether the cancer is progressing, instead of more aggressive treatment options such as surgery or radiation.2,3

"For men with low-risk, localized prostate cancer, the option of AS is regularly recommended; however, variation in PSA monitoring and the anxiety of having a ‘cancer’ diagnosis causes many men to leave surveillance management and undergo interventional treatment," said Neal D. Shore, M.D., FACS, ProVent principal investigator, medical director for the Carolina Urologic Research Center and a practicing urologist at Atlantic Urology Clinics in Myrtle Beach, S.C. "Both patients and physicians have desired a proactive therapy for appropriate AS patients in order to optimize their long-term outcomes. Given the numerous studies describing the effectiveness of sipuleucel-T immunotherapy for advanced prostate cancer, we are optimistic that data from ProVent may lead to the first-ever immunotherapy treatment option for men with early-stage prostate cancer."

About the ProVent Trial
The randomized, multicenter Phase 3 ProVent trial is assessing the efficacy of sipuleucel-T in reducing histopathologic disease progression in men on AS. Men age 18 or older who have histologically-proven adenocarcinoma of the prostate diagnosed within 12 months of randomization were eligible to enroll in the study, which is being conducted at approximately 60 sites across the United States. Study participants were randomized 2:1 to receive sipuleucel-T or remain on AS.

The primary endpoint is histological upgrade from ISUP Grade Group 1 to Grade Group 2 or higher, or Grade Group 2 upgraded to Grade Group 3 or higher at 33-39 months after randomization. Secondary endpoints include the number of study participants who receive subsequent prostate cancer treatment (e.g., surgery, radiation, hormone therapy), the percentage of participants with a negative biopsy, and safety. Exploratory objectives will evaluate quality of life and the association of immunologic responses with efficacy.

Enrollment in the ProVent study began in late 2018, and topline results are expected in 2023.

For more information, visit www.ProVentStudy.com or clinicaltrials.gov (NCT03686683).

About Active Surveillance (AS)
During AS, prostate tumors are not treated, but are regularly monitored via biopsies (every one to two years) and regular prostate-specific antigen (PSA) testing to determine disease progression. AS reduces the risk of overtreatment of clinically-insignificant prostate cancer while retaining the option of definitive therapy. AS is increasingly accepted as a treatment option for certain categories of prostate cancer.4 It is included in treatment guidelines from organizations including the American Urological Association, American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), and National Comprehensive Cancer Network.

About PROVENGE (sipuleucel-T)
PROVENGE is the only FDA-approved immunotherapy made from a patient’s own immune cells for the treatment of prostate cancer. More than 30,000 men have been prescribed PROVENGE, and it has been clinically proven to extend life for certain men in advanced stages of the disease.

INDICATION
PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.

IMPORTANT SAFETY INFORMATION
Acute Infusion Reactions: Acute infusion reactions (reported within 1 day of infusion) may occur and include nausea, vomiting, fatigue, fever, rigor or chills, respiratory events (dyspnea, hypoxia, and bronchospasm), syncope, hypotension, hypertension, and tachycardia.

Thromboembolic Events: Thromboembolic events, including deep venous thrombosis and pulmonary embolism, can occur following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events. PROVENGE should be used with caution in patients with risk factors for thromboembolic events.

Vascular Disorders: Cerebrovascular events (hemorrhagic/ischemic strokes and transient ischemic attacks) and cardiovascular disorders (myocardial infarctions) have been reported following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events.

Handling Precautions: PROVENGE is not tested for transmissible infectious diseases.

Concomitant Chemotherapy or Immunosuppressive Therapy: Chemotherapy or immunosuppressive agents (such as systemic corticosteroids) given concurrently with the leukapheresis procedure or PROVENGE has not been studied. Concurrent use of immune-suppressive agents may alter the efficacy and/or safety of PROVENGE.

Adverse Reactions: The most common adverse reactions reported in clinical trials (≥ 15% of patients receiving PROVENGE) were chills, fatigue, fever, back pain, nausea, joint ache, and headache.

On October 30, 2019 Lannett Company, Inc. (NYSE: LCI) reported that it will report financial results for its fiscal 2020 first quarter on Wednesday, November 6, 2019, after the market closes (Press release, Lannett, OCT 30, 2019, https://www.prnewswire.com/news-releases/lannett-to-report-fiscal-2020-first-quarter-financial-results-host-conference-call-on-wednesday-november-6-300947807.html [SID1234550081]). Lannett management will host a conference call that same afternoon at 4:30 p.m. Eastern Time to review the company’s performance and answer questions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The conference call will be available to interested parties by dialing 800-447-0521 from the U.S. or Canada, or 847-413-3238 from international locations, passcode 49151826. The call will be broadcast via the Internet at www.Lannett.com. Listeners are encouraged to visit the website at least 10 minutes prior to the start of the scheduled presentation to register, download and install any necessary audio software. A playback of the call will be archived and accessible on the same website for at least three months.